BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRONICS

    MDR report key: 12225753 · Received July 26, 2021

    Report

    Report Number
    2031642-2021-04415
    Event Type
    Malfunction
    Date Received
    July 26, 2021
    Date of Event
    July 21, 2021
    Manufacturer
    RESPIRONICS CALIFORNIA, LLC
    Product Code
    MNT
    PMA / PMN Number
    K102985
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    B4: (B)(6) 2021. PER REMOTE SERVICE ENGINEER (RSE) THE ISSUE WAS DISCOVERED OUTSIDE CLINICAL USE. NO DELAY IN THERAPY AND NO MEDICAL INTERVENTION REPORTED. THE FIELD SERVICE ENGINEER (FSE) REPLACED PCBA DATA ACQUISITION BOARD. RAN ALL RELATIVE TESTS THROUGH PRONTO FORMS. ALL TESTS PASSED.

    Additional Manufacturer Narrative · 0

    PATIENT INVOLVEMENT: THE CUSTOMER REPORTED THAT THE UNIT WAS NOT IN USE ON PATIENT AT THE TIME OF THE RE. THE ISSUE WAS DISCOVERED OUTSIDE CLINICAL USE. NO DELAY IN THERAPY AND NO MEDICAL INTERVENTION REPORTED.

    Additional Manufacturer Narrative · 0

    THE REMOVED PCBA DATA ACQUISITION BOARD (DAQ) WAS RETURNED TO THE FAILURE INVESTIGATION LAB (FI). THE FI TECHNICIAN INSTALLED THE PCBA DATA ACQUISITION BOARD (DAQ) INTO A FI VENTILATOR TO ATTEMPT TO DUPLICATE THE REPORTED ISSUE. THE PCBA DATA ACQUISITION BOARD (DAQ) WAS TESTED, AND THE CUSTOMER COMPLAINT WAS VERIFIED. ROOT CAUSE IS FAILURE OF BAROMETRIC PRESSURE SENSOR U5 (LOT 1631).

    Additional Manufacturer Narrative · 1

    DATE OF REPORT: 26JULY2021.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED BAROMETER SENSOR RANGE ERROR CODE. THE CUSTOMER REPORTED THAT THE UNIT WAS IN USE ON PATIENT, BUT NO PATIENT HARM WAS REPORTED. THE CUSTOMER CONTACTED PRODUCT SUPPORT AND REQUESTED FOR SERVICE REPAIR. FURTHER INFORMATION IS PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1122908 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS CALIFORNIA, LLC V60 PLUS

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown